Diseases such as nosocomial infections, hepatitis and AIDS, which are pathogens that can be transmitted with the body fluids of a person, are running rampant globally. As a result, medical environments such as hospitals spend considerable amounts of money, time and energy attending to the problems that arise when hypodermic needles are required.
Complex protocols are evolving which attempt to minimize the likelihood of a needle stick from the time that a needle has been removed from its sterile storage environment through loading, utilization and disposal. Examples of heightened care with respect to the use of hypodermic needles are chronicled in patent literature, in the development of anti-stick needle caps, devices which destroy the needle itself after use and other instrumentalities for receiving both the used needle and syringe for safe disposal. Thus, the prevailing systems are based on the premise of the very existence of the needle for the medicating process.
The instant invention to a large extent obviates the need for the needles themselves in the many common instances where syringe needles have heretofore been used. Typically, one scenario where the use of a hypodermic needle is now commonplace includes the steps immediately prior to injection in the patient. The process involves loading the syringe with a sterile, pharmaceutical-grade fluid by extracting medicating fluid from a vial by using the affixed needle of a syringe for access. When using an ampule, the tip is broken off and then the ampule is entered with a needle, often a filtered needle to filter out glass particles. Next, the patient who is to receive this medicating fluid is injected with a new needle.
Prior art drug containing vials are formed from an open mouthed bottle or jar wherein the walls of the container defining the vial are rigid and non-flexible. The opening of the jar includes a lip which supports a metal ferrule which supports an elastomeric diaphragm made from a rubber-type material having a resealable property such that once the diaphragm has been penetrated by a needle and then removed, the diaphragm reseals itself. Examples of these devices are believed to be presently classified in class 604, subclass 415. Typically, a syringe body is first fitted with a hypodermic needle. It is common practice that prior to the needle being plunged into the vial through the rubber diaphragm, it is first loaded with ambient air. Because the prior art vials are rigid, the vial is first pressurized to assist in fluid withdrawal. While this technique makes it easier to withdraw fluid, it introduces non-sterile air into the vial. Technically, the needle is to then be replaced with a new needle prior to injecting a patient.
The syringe is, in general, an elongate cylindrical object having a plunger adapted to reciprocate within an interior hollow. By withdrawing the plunger from the interior of the cylindrical hollow, fluid is drawn from the vial and is loaded into the syringe. Once the syringe has been removed from the vial, great care must be exercised for a multiplicity of reasons. The medication contained within the syringe is now provided with the present ability to discharge the medication to any who come in contact with the needle, albeit inadvertently. In order to reduce the amount of time a "loaded" syringe is carried, the medicating healthcare professionals normally will use a cart which contains all pharmaceuticals which are to be distributed during rounds to the patients. This reduces the amount of time the healthcare professional is required to walk with an armed syringe whose needle has been exposed or whose exposed needle has been recapped. Recapping provides further risk of self sticking due to misaligning a needle cap with the syringe.
After dispensing the medicine to the patient, the healthcare professional typically has one of several choices, none of which is entirely satisfactory for safe disposal of the needle. In one scenario, the healthcare professional is required to carefully recap the needle hoping that in the multiple times this procedure is reperformed he or she does not misalign the cap with the needle and inadvertently suffer a needle stick.
Another device has been developed which appears like a pencil sharpener and allows the healthcare professional to place the leading end of the syringe into an opening where an electric current is applied to the needle which melts the needle.
A third strategy involves discarding the needle and the syringe in a container for subsequent destruction or internment as biomedical waste. This technique presents ongoing risk to people who subsequently handle this waste.
The Food and Drug Administration (FDA) has accordingly issued an alert urging hospitals to use needleless systems or recessed needle systems instead of hypodermic needles for accessing intravenous lines. Plastic cannulas now exist which can fit onto luer connections and penetrate sealable diaphragms on infusion catheters. Thus, the FDA is urging the use of hypodermic needles only to penetrate the skin.
The following prior art reflects the state of the art of which applicant is aware and is included herewith to discharge applicant's acknowledged duty to disclose relevant prior art. It is stipulated, however, that none of these references teach singly nor render obvious when considered in any conceivable combination the nexus of the instant invention as disclosed in greater detail hereinafter and as particularly claimed.
U.S. PATENT DOCUMENTS U.S. PAT. NO. ISSUE DATE INVENTOR 829,178 August 21, 1906 Stegmaier 2,486,321 October 25, 1949 O'Sullivan 3,187,966 June 8, 1965 Klygis 3,419,007 December 31, 1968 Love 3,977,553 August 31, 1976 Cornett, III et al. 4,046,145 September 6, 1977 Choksi, et al. 4,130,117 December 19, 1978 Van Eck 4,213,456 July 22, 1980 Bottger 4,465,472 August 14, 1984 Urbaniak 4,643,309 February 17, 1987 Evers 4,944,736 July 31, 1990 Holtz 5,035,689 July 30, 1991 Schroeder 5,334,173 August 2, 1994 Armstrong, Jr. 5,356,406 October 18, 1994 Schraga 5,374,263 December 20, 1994 Weiler 5,409,125 April 25, 1995 Kimber, et al. 5,716,346 February 10, 1998 Farris FOREIGN PATENT DOCUMENTS PATENT NO. ISSUE DATE INVENTOR FR 2594-687-A August 28, 1987 Hosnedl EP 0 324 257 .sup. July 19, 1989 Smiths Industries EP 0 350 772 .sup. January 17, 1990 Hansen
Evers (see for example FIGS. 3 or 6) only connects with a syringe because its "container (1) is provided with an outlet opening (2) having a surface in the form of an outwardly widening truncated cone" (see column 2, lines 27-29).
When the Evers device is installed on a syringe tip the vial (1) must first be axially advanced to the right of the Evers right-hand side drawing. This causes a radial force by distending the outwardly widening truncated cone (2). Once the axial force is no longer applied, there is still a tendency or a reaction of the plastic material forming the outwardly widening truncating cone (2) to return to its original unstressed configuration. Since the cone is acting on a surface which is canted with respect to the long axis of the vial, the surface has a force component parallel thereto which encourages the vial to slide off from the syringe. Evers featured a second embodiment (FIG. 6) wherein the opening "has been provided with peripherally arranged interior annular grooves across the outlet direction. Grooves of this kind apparently give improved sealing for the syringe tip (8) especially if the outlet opening is made of very thin and flexible plastic material." (Column 3, lines 4-8.)
Kimber, et al. provides a neck portion (3) (FIGS. 2 and 5), but this is not the area of frangibility. Fracture occurs above the neck portion at outlet opening (7) and threads are located in the area between the opening (7) and the neck portion (3). These threads are intended to coact with the internal threads (15) carried on the peripheral wall (12) of a conventional luer coupling on the syringe. The threads are advanced until they bottom out against a bottom wall (13) on the luer coupling.
Holtz teaches the use of a cap interposed between the syringe and the vial. Holtz, column 3, lines 32, et seq. states "since the cap (5) makes the assembled bottle and adapter (1) completely sealed and caps (12) and (14) make the syringe completely sealed these two assemblies may be carried loose . . . with no fear of contamination . . . ". Thus, the cap (5) and adapter (1) remain with the vial while the caps (12) and (14) remain with the syringe.
Stegmaier teaches the use of a cap tailored to never be reinstalled so as to prevent the bottle from being refilled. Thus, the portion that has indicia thereon includes a frangible section which precludes and "obviates the likelihood of refilling" (column 1, lines 10-11). Thus, once the cap has been removed from the bottle, it is never possible to be reattached. Thus, any indicia on the cap has limited value because it cannot be reassociated with the syringe that contains the contents heretofore in the vial.
Hansen teaches a vial constructed to more easily remove the tab, allowing access to the vial's interior.